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Senior Validation Engineer III

Job Title: Senior Validation Engineer III
Contract Type: Contract
Location: Cork
REF: 81493
Job Published: over 1 year ago

Job Description

Senior Validation Engineer III

Our client, a medical device company in Cork are currently looking to recruit a Senior Validation Engineer on an hourly contracting basis.

  • The Validation Engineer is a member of the QA Validation team, playing a key role in the planning and execution of validation activities related to project.
  • Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of facilities.
  • All validation activities are conducted in compliance with US and EU legislation; as well as company Standards and Guidelines to allow a facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget.

  • Conduct validation activities in compliance with US and EU regulations, GBSC procedures and EHS requirements.
  • Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
  • Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
  • Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
  • Execute qualification protocols as required.
  • Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
  • Prepare reports of executed protocols for review by QA.
  • Initiate and implement change control activities in accordance with site procedures.
  • Track and resolve exceptions during qualification activities.
  • Prioritize qualification activities in line with the project schedule.
  • Co-ordinate qualification activities with engineering, construction and commissioning activities.
  • Co-ordinate qualification activities with contractors and vendors as required.
  • Co-ordinate qualification document review and approval.
  • Collate and organize qualification files for turnover to QADC.
  • Attend identified training, required to fulfil the role of Validation Engineer.
  • Assist in the development of training material for qualification activities. ?
  • Participate in cross-functional teams as required.
  • Deputises for the QA Validation Manager when designated as appropriate.
  • Domestic and international travel may be required.

Other Skills, Experience and Education
  • A degree qualification in science or engineering.

  • The person will have a proven track record in the qualification of any of the following systems:
  • Qualification of Cell Culture Technologies.
  • Qualification of Purification - Chromatography and Ultrafiltration Technologies.
  • Qualification of Production Support Equipment.
  • Qualification of Clean Utilities.
  • Qualification of HVAC (ISO classes 5 to 8).
  • Qualification of Control Systems - Emerson DeltaV, Honeywell Building Management Systems and Siemans PLCs. Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries. Knowledge and Interpretation of FDA/EMEA requirements applicable to the pharmaceutical or biopharmaceutical industries. Ability to apply CGMP regulations and guidelines to all aspects of qualification activities.

Key Competencies Required
  • Excellent interpersonal skills
  • Ability to operate as part of a team is critical and also the ability to work alone as required
  • Customer focus
  • Excellent communication skills both written and verbal
  • Attention to detail
  • Good problem solving skills
  • Results and performance driven
  • Adaptable and flexible

For further information on this Senior Validation Engineer role in Cork please contact Anne on 0212066287 /
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